MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for MESHGRAFT II INSTRUMENT ONLY 00219500100 manufactured by Zimmer Surgical, Inc..
[186693105]
This event has been recorded by zimmer biomet under (b)(4). This report is being submitted as an initial final report. Device evaluations results/investigation findings: product review of the meshgraft ii by zimmer biomet (b)(4) on march 6, 2020 revealed that there was a failure with the cutter blade and side plate. Repair of the meshgraft ii was performed by zimmer biomet (b)(4) on march 6, 2020 which included replacement of the cutter and sideplate. Meshgraft ii, serial number (b)(4), was then tested and functioned properly. Probable cause/root cause: the root cause of the reported event could not be specifically determined with the information that was provided. During the product review by zimmer biomet (b)(4) there was no mention of the ratchet handle not operating as intended. It is unknown with the information that was provided how this occurred. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time. This complaint will be tracked and trended for any adverse trends that may warrant further action.
Patient Sequence No: 1, Text Type: N, H10
[186693106]
It was reported that the mesh graft2 was need of repair for ratchet handle not move up and down. Event occurred during kit inspection. No adverse events were reported as a result of this malfunction. No additional event information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00323 |
| MDR Report Key | 9888809 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2019-12-05 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MESHGRAFT II INSTRUMENT ONLY |
| Generic Name | EXPANDER, SURGICAL, SKIN GRAFT |
| Product Code | FZW |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2019-12-02 |
| Catalog Number | 00219500100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |